drugset / Trial / NCT05315167

A Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects with Advanced Solid Tumors

NCT05315167 ↗

Phase 1/2 Recruiting 267 enrolled Zhuhai Yufan Biotechnologies Co., Ltd
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a multicenter, open-label study to assess the safety and preliminary efficacy and to determine the maximum tolerated dose (MTD) or maximum administration dose (MAD) and recommended Phase 2 doses (RP2D) of PRJ1-3024 in subjects with relapsed/refractory solid tumors. The study consists of two parts, one is a 3+3 dose escalation study and another is a pharmaceutical extension of RP2D.

Timeline

Start
2022-05-30
Primary completion
2027-05-15
Completion
2027-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject PRJ1-3024 Small molecule 80 mg Oral